On June 11, 2026, the US Department of the Treasury’s Office of Foreign Assets Control (“OFAC“) published in the Federal Register the List of Medical Devices Requiring Specific Authorization under the North Korea Sanctions Regulations, 31 CFR Part 510 (“NKSR“). The export or reexport of these excluded non-US medical devices to North Korea requires a specific license from OFAC if US Persons are involved. Other non-US medical devices remain eligible for export/reexport to North Korea by US Persons under an OFAC general license issued on February 16, 2024.
The List of Medical Devices Requiring Specific Authorization is organized into two categories: “General Medical Supplies and Equipment” and “Laboratory” items. The composition of the List reflects a focus on dual-use laboratory and equipment with potential proliferation sensitivity, rather than routine clinical or patient-care devices. OFAC has used this “general authorization subject to a published exclusion list” approach in other US sanctions programs and these exclusion lists are very similar. The NKSR’s List of Medical Devices Requires Specific Authorization is the same as the exclusion list under the Iranian Transactions and Sanctions Regulations, except that the NKSR list also includes spectrometers and fluorescence-activated cell sorters.
Like the NKSR’s comprehensive US sanctions targeting North Korea, the Export Administration Regulations, 15 CFR Part 730 et seq. (“EAR”), also impose a comprehensive export/reexport ban on North Korea. Under 15 CFR § 746.4, an export license is required for US and non-US parties to export or reexport any item subject to the EAR to North Korea (which would generally include US-origin items and non-US made items with US content exceeding 10%), except food and medicines classified as EAR99. Accordingly, a US-origin medical device (or other item subject to the EAR) destined for North Korea will generally require a US export license unless a license exception, such as License Exception GFT, is available. Under NKSR § 510.520, US Persons may be involved in exports or reexports to North Korea of items subject to the EAR if authorized under the EAR.
